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Call for proposals

EUROPEAN REFERENCE LABORATORY NETWORK FOR TUBERCULOSIS (ERLN-TB) - TO STRENGTHEN TB DIAGNOSIS, DRUG

SUSCEPTIBILITY TESTING, AND INTERNATIONAL COORDINATION - GRANT/2009/004

1. OVERVIEW .....................................................................................2

1.1. Title ............................................................................................................2 1.2. Background................................................................................................2

2. IMPLEMENTATION OBJECT OF THE CALL FOR PROPOSALS ..................................................................................5

2.1. Overall objective ........................................................................................5 2.2. Specific objectives of the call for proposals ...............................................5 2.3. Main actors of the management and communication ................................6 2.4. Deliverables of the call for proposals .........................................................7 2.5. Work Packages and activities ..................................................................10 2.6. Meetings: .................................................................................................15 2.7. Place of performance of the contract .......................................................16 2.8. Expected time frame ................................................................................16 2.9. Characteristics of the agreement object of the call of proposals .............17 2.10. Work Packages and related activities ......................................................17 2.11. Amount available for financial support and provisions about the

results ......................................................................................................20 2.12. Reporting requirements ...........................................................................20 2.13. Payments .................................................................................................21 2.14. Indicative time frame 1st year ..................................................................21 2.15. Implementation of the Work Packages in years 2 to 4.............................22

3. CONTENT OF THE APPLICATION...............................................22

3.1. THE DEADLINE FOR APPLICATION IS 3 JUNE 2009...........................22 3.2. The proposal to submit to ECDC should include: ....................................22 3.3. Management and Communication Plan...................................................22 3.4. Estimated budget .....................................................................................23

4. EVALUATION OF THE PROPOSALS...........................................23

4.1. Verification of submission requirements ..................................................24 4.2. Eligibility criteria .......................................................................................24 4.3. Exclusion criteria......................................................................................24 4.4. Selection criteria ......................................................................................25 4.5. Award criteria ...........................................................................................27

5. ANNEXES .....................................................................................28

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1. OVERVIEW

1.1. Title

EUROPEAN REFERENCE LABORATORY NETWORK FOR TUBERCULOSIS (ERLN-TB) - TO STRENGTHEN TB DIAGNOSIS, DRUG SUSCEPTIBILITY TESTING, AND INTERNATIONAL COORDINATION

1.2. Background

According to its mandate, the European Centre for Diseases Prevention and Control (ECDC) is currently establishing an integrated European surveillance system with one database for the European Union. As part of this process, it will assume responsibility for the surveillance of the diseases outlined in Decision 2000/96/EC which includes tuberculosis. In the ECDC founding regulation (851/2004 EC) it is clearly stated that ECDC within its mandate shall coordinate the surveillance activities at the Community level as well as other activities important for identification, assessment, and communication of emerging threats to human health from communicable disease. Within this broad mission statement, the Centre organized work in the general area of microbiology cooperations and also in the disease specific area of tuberculosis as described in the following sections.

ECDC’s disease specific programme on tuberculosis The programme was set up in 2006 and covers all aspects of Tuberculosis (TB), a disease that remains an important threat to human health world wide and in Europe. Despite the fact that the situation concerning TB in the European Union (EU) has dramatically improved over the past decades, TB continues to be a threat to the health of European citizens. It is considered a re-emerging disease of European importance due to: • an increasing global problem with multidrug-resistant TB (MDR TB) and extensively drug-resistant TB (XDR TB) that also affects Europe; • high burden of the disease in vulnerable populations where TB tends to disproportionately affect high risks individuals; and • medium to high TB incidence in some EU Member States as well as a number of the neighbouring countries. The key general and specific objectives of the programme can be found at http://ecdc.europa.eu/en/Health_topics/tuberculosis/ . Most relevant for the current Call for Proposal is the sections of the Framework Action Plan to fight Tuberculosis in the European Union1 concerned with strengthening laboratory …. and development of new tools.

1 http://ecdc.europa.eu/en/files/pdf/publications/080317_TB_Action_plan.pdf

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EuroTB and molecular surveillance Before ECDC was established, the surveillance of tuberculosis (TB) at the European level was performed by a dedicated surveillance network (DSN) called “EuroTB”. EuroTB has coordinated the surveillance of TB in the 53 countries of the WHO European Region for the last ten years. The network was co-funded by the European Commission and the Institut de Veille Sanitaire (InVS, France) and the coordinating hub was hosted in InVS. The contract with the European Commission (DG Sanco) expired on December 31st, 2007. From 2008 forwards ECDC and WHO/EURO agreed to continue jointly the future surveillance of TB for the entire WHO European Region in sharing the data sent by the 53 States, the activities deriving from the collection, validation, analysis and dissemination of information and other tasks related to surveillance and monitoring of tuberculosis. The molecular subtyping initiatives at the EU level have a long and successful history but important to recognize was the integration of the work of “Molecular Surveillance of Multidrug Resistant Tuberculosis in Europe” (MDR-TB project) as part of the 2005-2007 activities of EuroTB. The “MDR-TB project” developed out of concerns about the spread of drug-resistant tuberculosis in the European Union (EU), notably in the context of the eastwards expansion of the Union and the growing importance of imported TB. The work will be continued in collaboration with ECDC by:

• Describing and monitoring the types of MDR M. tuberculosis complex strains circulating in the EU Member States, Norway, Iceland and Liechtenstein;

• Identifying international molecular clusters of MDR-TB strains over time so that coordinated control action could be taken;

• Describing the prevalence and incidence of MDR-TB in Europe.

A future network of TB reference laboratories could support this initiative. Building synergy with pan-European and global TB initiatives In addition to the above Commission supported initiatives, such as EuroTB, DG RTD (Directorate General for Research and Development) have been funding tuberculosis projects of public health relevance (i.e. diagnosis, vaccine and drug development) for a number of years as part of the Framework programmes (FP), FP4, FP5, FP6 and recently FP7 under the area of “Poverty Related Diseases”2 . It is in FP7 where there are some critical projects underway that will improve diagnosis of drug resistance strains. It is therefore an ideal time to synergize with these efforts with a TB reference laboratory network as a platform to bring developments at the bench quickly to application in the field across the EU Member States and beyond. Furthermore, the EU involvement with WHO initiatives3 in their STOP TB programme as supranational laboratory services and linked programmes will be further strengthened by more formally supported EU networking and added value activities.

ECDC and cooperation with microbiology laboratories 2 Please refer to past projects and programmes funded by the Commission via the web portal

http://cordis.europa.eu/search/index.cfm

3 http://www.who.int/tb/en/

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ECDC does not have and will not have in the foreseeable future any laboratories of its own on site and relies on the MS expertise and laboratory capacities to support ECDCs specific public health core functions and disease specific work within its mandate and reflected in the annual and multi-annual workplans. Details of ECDC’s mandate and functions are set out in the above referenced Regulation, accessible through the ECDC web site but notable here is ECDC’s role stated in Article 5 related to networking activities in terms of:

a. supporting networking activities of the competent bodies recognized by the MS

b. encouraging cooperation between expert and reference laboratories

c. fostering development of sufficient capacity within the Community for diagnosis, detection, identification, and characterization of infectious agents which may threaten public health

d. maintaining and extending cooperation and supporting the implementation of quality assurance schemes

ECDC is continuing its work on implementing strategies for cooperations with microbiology laboratories and research institutes to further define ECDCs needs and role and added value in strengthening European public health microbiology and the role of the Member States, the Commission, ECDC, WHO partners and other key stakeholders to achieve this in the short term and as part of a long term vision. As part of this strategy, the first steps towards realizing a long term vision is to have a clear idea of what capacity and expertise currently exists in the EU and areas that need strengthening in the MS and EU-wide.

ECDC supported a study4 in 2007-2008 about the current situation and future areas of work needed in the field of tuberculosis, particularly reference level services and methods at national and supranational levels. From these findings ECDC has identified areas where there would be an EU added value for networking and building synergies with existing programmes funded by other sources. These include networking of reference laboratories for TB diagnosis, treatment follow-up, and susceptibility testing to first and second line drugs as an important tool towards controlling TB in the MS and to monitor the spread of multi-drug resistance strains. There is the need that laboratories in the MS, that have expertise in providing reference services in Tuberculosis, are brought together in a network and elaborate on these specific areas and on concrete deliverables for 2009-2010 and beyond.

Good laboratory services in the countries are essential for strengthening the EU level surveillance and follow-up public health actions. This statement is particularly valid in the case of MDR-TB. A lot has been achieved through the public health and research laboratory networks, in the former EuroTB and the DG Research funded projects, to improve and standardize laboratory methodology and systems. The ECDC will build on this work and support the strengthening of the laboratory capacity in the Member States (MS), EEA-EFTA countries and the candidate countries in collaboration with the

4 Drobniewski FA, Nikolayevskyy V, Hoffner S, Pogoryelova, O, Manissero D, Ozin AJ. The added value

of a European Union tuberculosis reference laboratory network – analysis of the national reference laboratory activities. Euro Surveill. 2008;13(12):pii=8076. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=8076

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Commission, the WHO, and the ECDC competent bodies, including the recently nominated National Microbiology Focal Points5,6 who serve as an advisory body for general microbiology issues.

2. IMPLEMENTATION OBJECT OF THE CALL FOR PROPOSALS

2.1. Overall objective

Within the context of the “Framework Action Plan to fight Tuberculosis in the European Union”, this contract objectives aim to strengthen European TB laboratory services in the EU:

2.2. Specific objectives of the call for proposals

• Develop a well functioning EU reference laboratory network that builds on and synergises with activities covered by other supranational/global initiatives, with the capacity to serve and support EU MS and the European Region, with a specific focus on the challenges of TB control and elimination in the EU setting.

• In particular, this network will improve access to and performances of mycobacterial laboratories in order to ensure the provision of reliable and timely diagnosis services and implementation of current and future needs and responsibilities in the TB field. These pan-European services/activities shall include:

- REFERENCE SERVICES: international laboratory technical support and access to diagnostic services (i.e. access to drug susceptibility testing through twinning or other contractual arrangements) particularly for countries with small case loads or infrastructures in transition. Such collaborations are expected to strengthen routine and enhanced surveillance initiatives. - METHODS HARMONISATION: development and/or maintenance of standardized and/or harmonized methods (n.b. while this is a particularly high priority for second line drug testing, it is relevant for the whole spectrum of new and traditional diagnostic methods); - EXTERNAL QUALITY CONTROL: promotion of the implementation of existing WHO and other external quality assurance (EQA) systems and development of new external quality assurance systems (e.g. typing and rapid molecular diagnosis); - TRAINING: training opportunities through workshops, staff exchanges, access to training material;

5 http://ecdc.europa.eu/en/Activities/Microbiology/focal_point.aspx

6Paper for the ECDC Management Board (MB) on 27 November 2007. MB11/11 “General Strategy and Framework of Actions (2007-2013) for ECDC Cooperations with Microbiology Laboratories” http://ecdc.europa.eu/en/Activities/Microbiology/documents/MB11-11%20Labs%20strategy.pdf

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- PERFORMANCE ASSESSMENTS: possibilities for peer-review of laboratory performance and implementation of standards; - INFRASTRUCTURE DEVELOPMENT: use of the laboratory networking activities as a platform for development and/or validation of new diagnostic methods or devices

2.3. Main actors of the management and communication

Definitions for the following actors of the management and communication aspects of the project are described below:

Coordinating partner – is the host institute, organisation, and/or private company that will have overall responsibility for the project. The coordinating partner should organise the following roles/functions to ensure project implementation: a Project Leader, who will act as the lead for the coordination and work of the ERLN-TB network and a Project Administrator who will have the overall responsibility for day-to-day project coordination and management. Both the Project Leader and Project Administrator are the key contact persons for liaising with ECDC and with Associate Partners. The Project Leader and Project Administrator should both be employed by the Coordinator as one individual or as separate roles.

ERLN-TB = European reference laboratory network for TB; refers to a network of laboratories/laboratory experts consisting of members from 27 EU Member States, EEA/EFTA countries (Norway, Iceland and Liechtenstein), candidate countries (Croatia, Former Yugoslav Republic of Macedonia and Turkey)

Partners - are the ERLN-TB members that will form the consortium as a result of work package 1 (WP1 – described below). They are responsible for conducting part of the work plan at a regional or national level, are expected to contribute technical expertise, and play a key role in obtaining relevant data for the project as appropriate.

Management team – consists of 3-5 people including the Project Leader and selected representatives from Partners. The Management Team should select a chairperson to run the meetings and is expected to meet with the Steering Committee regularly throughout the project duration and not less than once every 6 months. The Management team shall technically and strategically contribute to the Project Leader’s work and shall liaise with existing groups and projects funded under the ECDC, Commission, and WHO.

Steering Committee – will be established to oversee project activities and to ensure the quality and relevance for the European added value of the project. The Steering Committee will be formed by the ECDC, in consultation with the beneficiary of the partnership agreement. The Steering Committee will include the successful Applicant, ECDC staff member(s), and 2 - 3 TB/Public Health experts appointed by ECDC.

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The ERLN-TB partners shall act in agreement and co-ordination with the designated ECDC project manager/scientific officer on the ECDC Tuberculosis programme.

2.4. Deliverables of the call for proposals

The work to be carried out under the agreement to be awarded is organised in the following three main Work Packages (WPs) and the related deliverables.

Defintions and acronyms: D = deliverable m = month; Used to describe timing within the expected total of 48 months (4 years) of this framework agreement WP1. THE EUROPEAN REFERENCE LABORATORY NETWORK FOR TUBERCULOSIS (ERLN-TB) IS FULLY ESTABLISHED AND ITS CO-ORDINATION IS ENSURED

WP1.1 ANNUAL MEETING AND CO-ORDINATION

D1.11 – the TB reference laboratory network (ERLN-TB) with agreed members is set up (m1-3)

D1.12 – an annual meeting is organised with all ERLN-TB network members and meeting notes are provided (propose first meeting to be held between m3-6)

D1.13 – an annual report on project implementation, comprising all the Work Packages (see below), is provided (propose reporting periods m12, 24, 36, 48)

WP1.2 ERLN-TB MANAGEMENT TEAM

D1.21 – a ERLN-TB management team with agreed members (maximum 5) is set up (m1-3)

D1.22 – regular feedback (monthly teleconference and meeting notes/minutes) from ERLN-TB management team meetings is provided (m1-48)

WP1.3 METHODS HARMONISATION

D1.31 –a handbook of TB diagnostic methods, which includes the establishment of standards, is compiled (m12)

D1.32 - a workplan/roadmap for methods harmonisation (m12 – annex of annual report or separate document) is provided including the following chapters:

• provide list of areas/methods where standards development is feasible, useful,

and would give EU added value (i.e. DST testing, in particular for second line drugs and description of cut-off points)

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• provide overview of projects/initiatives at EU level where methods are

currently being harmonised (i.e. please include EU-CAST, Molecular subtyping projects, DST projects under the WHO and EC support etc…)

• provide a roadmap of plans for merging the ongoing activities and identify

future activities of this network for harmonization of methods D1.33 – the workplan of D1.32 is implemented and interim internal reports/feedbacks on milestones and work progress are provided (m12-48)

D1.34 – a revised handbook (technical guidance) of D1.31 is produced including outputs of D1.32-1.33 work for methods in TB laboratories (m48) and link work to the training activities in WP 3 (m7-48)

WP1.4 REFERENCE SERVICES

D1.41 – a list of available and needed reference services and relative costs per service are developed with the ERLN-TB partners (m7)

D1.42 – annual feedback on acting collaborations and on the use of these reference services (part of the annual reports m12, 24, 36, and 48)

WP1.5 EU STRAIN/SAMPLE COLLECTION

D1.51 – a workplan/roadmap for development of an EU strain/sample collection is provided (m12 – annex of annual report or separate document)

D1.52 – a workplan is implemented and an interim report on milestones and work progress is provided (m7-48)

WP1.6 ALERT and RESPONSE

D1.61 – ERLN-TB participate in and promote ECDC’s alert and response collaboration platforms to TB colleagues/community of experts (m1-48; part of management teamwork and/or annual meetings)

D1.62 – annual feedback on contributions of TB experts to alert and response systems of ECDC (part of the annual reports m12, 24, 36, 48)

WP1.7 SCIENTIFIC EXCELLENCE and ADVICE

D1.71 – ERLN-TB partners participate in and promote ECDC scientific expert activities to TB colleagues/community of experts (m1-48; part of management team work and/or annual meetings)

D1.72 – scientific articles are produced from ERLN-TB activities (see section 2.11 – subject of contract for details) – (m1-48)

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WP2. EXTERNAL QUALITY ASSURANCE (EQA) SCHEMES ON PROVISION AND PROMOTION OF TB LABORATORY METHODS ARE PLANNED AND BASELINE PERFORMANCE ESTABLISHED

WP2.1 ESTABLISHMENT OF THE CURRENT PERFORMANCE

D2.11 – information of past proficiency exercises is compiled and design of next phase of proficiency testing rounds to establish baseline in needed areas is prepared (m1-3 planning phase)

D2.12 – a baseline of performance is established (i.e. execute a proficiency testing round with ERLN-TB partners) for selected first and second line drugs and other needed areas based on D2.11 (m3-7 execute phase of EQA rounds, report as part of first annual report m12 and/or separate scientific paper of results)

WP2.2 DEVELOPMENT OF FUTURE EQA SCHEMES

D2.21 –a workplan/roadmap for development of an EQA system including the following chapters is provided: (m12 – annex of annual report or separate document)

• provide background/overview which includes references to existing EQA schemes and standards and/or projects and related initiatives at EU level where EQA activities are being applied

• provide a list of areas/methods where EQA programmes are feasible, useful, and would give EU added value (i.e. microscopy, culture detection, DST testing, in particular for second line drugs and measurement of cut-off points)

• provide roadmap of plans for merging the ongoing activities and for identification of future activities of this network in the area of EQA

• identify ongoing training or future plans to use training to support improvements of performance for meeting EQA standards (refer to Work Package 3 on training for improving EQA performance)

WP2.3 IMPLEMENTATION OF REGULAR EQA ROUNDS, DATA MANAGEMENT and ANALYSIS

D2.31 – workplan established in D2.21 is implemented and interim feedback on milestones and work progress is provided as part of follow up EQA rounds (m12-48)

D2.32 –data management solutions and integration of laboratory data into TESSy where appropriate is arranged in collaboration with ECDC and where relevant to the mandates of the ECDC Tuberculosis programme (m12)

D2.33 - an annual summary report of EQA data analysis is produced (m12-48; reports of EQA can be as part of the annual reports or separate documents). A version of the report is sent to the participants with anonymised data. The full report should however include

• summary and analysis of the results after each of the testing rounds and comparison to the established baseline (D2.12)

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• concrete recommendations for future EQAs and any areas where the training could help to strengthen any methods or procedures where results were below optimal.

WP3. TRAINING IS PREPARED AND TRAINING INITIATIVES IMPLEMENTED, WITH THE OVERALL AIM TO STRENGTHEN MS CAPACITY IN TB DIAGNOSIS, DRUG SUSCEPTIBILITY TESTING, AND INTERNATIONAL COORDINATION

WP3.1 IDENTIFY TRAINING NEEDS

D3.11 - training needs in laboratory methods, diagnostics and other areas are identified in EU, EEA/EFTA Member States and candidate countries (m1-7)

WP3.2 IMPLEMENTATION OF TRAINING PROGRAMMES

D3.21 - a curriculum and training materials and initiatives are developed and implemented for laboratory workshops, EQA task forces, and for laboratory exchange programmes (m7-48)

2.5. Work Packages and activities

The successful applicant is requested to coordinate their work in agreement with and under the supervision of ECDC. The applicant should agree that online submission tools and the databases should be integrated in The European Surveillance System (TESSy) or other online submission tools at the ECDC in Stockholm as appropriate to the tasks described. This will ensure safe on-line access to the database for the ECDC, for nominated TB laboratory contact points, contact points for TB surveillance, main contact points for general surveillance and any persons nominated or authorized by them.

WP1. THE EUROPEAN REFERENCE LABORATORY NETWORK FOR TUBERCULOSIS (ERLN-TB) IS FULLY ESTABLISHED AND ITS CO-ORDINATION IS ENSURED

Following the definitions of the roles of the actors of the project (see section 2.3) the successful applicant shall act as the Coordinating partner of the ERLN-TB. The tasks of WP1 consist of setting up and ensuring continued coordination of the ERLN-TB.

The Project Leader coordinates and runs the ERLN-TB. The ERLN-TB should be composed of approximately one official National Reference Laboratory (NRL), or laboratory fulfilling this function, from each member state. For MS where there is no recognizable reference function then a viable alternative is the nomination of a national TB laboratory representative/expert.

The process of nomination of the members of the ERLN-TB will be done together with ECDC in month 1-3 of the project. This will include a process of consultation with the ECDC's Competent Bodies and relevant National Microbiology Focal Points. After which, the members of the ERLN-TB will be requested by ECDC to become consortium partners to this Framework agreement and give a mandate to the ERLN-TB coordinator (see Annex IIIB).

WP1.1 ANNUAL MEETING:

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• Identify/confirm the network participants and organise an annual meeting of the

group consisting of management team, members from all EU Member States (MS), EEA-EFTA countries and the candidate countries, and identified key stakeholders from the Commission and the WHO (max. 40 persons).

• The venue for the first and the last annual meetings should be arranged at the

ECDC premises in Stockholm; however other options can be discussed.

• Give scientific input as contribution to the professional agenda/seminars/talks in these annual meetings.

• Cover the travel, accommodation and relevant subsistence expenses for all the

participants. Travel, accommodation and subsistence for ECDC staff will be covered by ECDC according to its internal procedures. Expenses by the consortium should be included in the budget estimation. Organise the meeting as indicated below in section 2.5

WP1.2 ERLN-TB MANAGEMENT TEAM

• Referring to description in section 2.3; propose a small number (e.g. maximum 5) of representatives from the ERLN-TB group who shall liaise with existing groups and projects under the ECDC, Commission, and WHO. The terms of reference for the management team shall be developed jointly with ECDC.

• Cover the travel, accommodation and relevant subsistence expenses for the management team members and any additional invited participant to meet outside of the annual meetings. It is expected that a maximum of 3 meetings (1-2 days) will be necessary each year and teleconferencing should be used in between face-to-face meetings.

• Travel, accommodation and subsistence for ECDC staff will be covered by ECDC. Expenses by the applicant should be included in the budget estimation. Organise the meeting as indicated below at section 2.5.

WP1.3 METHODS OF HARMONISATION:

• Propose a roadmap and implementation plan for harmonization of TB laboratory methods in needed areas, taking into account ongoing projects at the EU/international levels.

• Produce a European “handbook” (technical guidance) of harmonized methods as the ultimate output of the network to be used as a tool to share amongst reference laboratories and regional labs. Include, in the list of methods to consider, drug sensitivity testing and breakpoints, molecular subtyping, and classical microscopy and culture methods. Consider also biosafety and sample/specimen handling protocols. Adapt and link the methods harmonization to the WP3 on training.

WP1.4 REFERENCE SERVICES: Provide reference service “menu” and promote access to these laboratory services to consortium partners and/or third parties as appropriate to fulfill the deliverables of the

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work packages for the ERLN-TB (i.e. molecular subtyping, drug susceptibility testing, etc…) and other basic services identified by the consortium partners.

WP1.5 EU STRAIN/SAMPLE COLLECTION: Propose the development, maintenance, and use of a European strain collection. This can include EQA panels or other important clinical strains of EU added value as a public health resource. For those strains that require specific biosafety levels (BSL) and conditions for handling (i.e. specific (clinical) strains for second line drug testing or which are multidrug resistant) propose how to maintain overview and justify the decision making process to release specific strains according to participating EU reference laboratories, including procedures to demonstrate required competency and biosafety requirements satisfaction. WP1.6 ALERT and RESPONSE Involve the ERLN-TB experts in contributing to and developing the scientific advice expert community and future alert systems being developed by ECDC (i.e. the epidemic intelligence web platform for exchange of information on TB outbreaks, clusters or other unusual findings related to TB). WP1.7 SCIENTIFIC EXCELLENCE and SUPPORT: ERLN-TB laboratory experts produce at least one peer-reviewed article per year on the TB activities or data covered in the framework agreement and contribute to the scientific advice expert community of ECDC and encourage also qualified colleagues to explore scientific collaborations with ECDC.

WP2. EXTERNAL QUALITY ASSURANCE (EQA) SCHEMES ON PROVISION AND PROMOTION OF TB LABORATORY METHODS ARE PLANNED AND BASELINE PERFORMANCE ESTABLISHED

• The applicant prepares an approach on how to provide and promote EQA

schemes to be used by national reference laboratories (and for applying this to networks of regional public health TB laboratories) for diagnostic methods in TB (culture and microscopy) and first and second line drug testing in order to ensure that laboratories of the ERLN-TB partners and beyond produce reciprocally comparable and valid data..

• Develop also outline plans for new diagnostics methods and techniques, including

line probe assays, Interferon Gamma Release Assays and the like tests listed under international retooling initiatives7.

• Expand on an approach for standardization of molecular typing methods and for

molecular sub-typing under development in a separate ECDC funded project.8

7 http://www.stoptb.org/researchmovement/

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The successful applicant shall in close collaboration with ECDC relevant project manager ensure close interaction.

• The ERLN-TB Management team gets involved with this activity and guides the

development of methods, protocols, services, and follow-up training needs (see WP3) proposed as part of the EQA system.

Approach should take into account inclusion of the ERLN-TB partners from the 27 EU Member States, EEA/EFTA countries (Norway, Iceland and Liechtenstein), candidate countries (Croatia, Former Yugoslav Republic of Macedonia and Turkey) and also consider justifications/planning for dissemination of the work to other relevant regional, neighbouring and/or third countries Moreover, the approach should identify and take into account related ongoing activities/projects financially supported by the Commission and how they intersect with global initiatives supported by the WHO to build synergies and to avoid duplications.

It is not expected that the applicant will be the specialist for all techniques concerned in the EQA programmes proposed and in this case arrangements with appropriate specialists in the consortium – or private companies – can be used to fulfil part or all of the tasks of this EQA WP2. For each of the deliverables in WP2 the applicant is asked in the final report of the project (month 48) to provide a description of the processes and cost breakdown for each programme that has been performed and the basic steps of each services/programme (see list i-iv below for guidance) in relation to the steps that have been used during WP2 implementation (See Annex VIII on budget):

i) “Panel Selection” – Selection of representative isolates for the EQA panel according to specified criteria and in dialogue with the appropriate reference bodies in the field

ii) “Panel Confirmation” – Confirmation of the phenotypic and genotypic characteristics of each strain to be included in the panel (before and after preparation for distribution as appropriate).

iii) “Panel Preparation and Distribution” – preparation of the cultures, freeze drying, and distribution to participating laboratories at defined time in the year according to International Legislation for shipments.

iv) “Analysis and Reporting” – network will put together in annual report the results from the participating laboratories anonymously for each EQA round and recommendations for further developments in EQAs and any areas where training could help to strengthen any methods or procedures where results were not optimal.

WP2.1 ESTABLISHMENT OF THE CURRENT PERFORMANCE:

8 ECDC Call For Tender – awarded in 2009 “Management of the molecular typing activities of MDR-TB

strains at EU level”

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Using experiences from currently existing TB EQA initiatives, design a proficiency round in agreed selected areas of TB diagnostic services (e.g. microscopy, culture, DST, subtyping etc…) to establish a baseline of performance for 2009 of the ERLN-TB partners and to help identify future needs for collaboration of the network and training needs (refer to WP3 of training and use of task forces to improve proficiency testing performance). WP2.2 DEVELOPMENT OF FUTURE EQA SCHEMES: Identify areas where an EQA scheme exists and/or should be developed; including diagnostic methods in TB (culture and microscopy), first and second line drug testing, molecular diagnosis and molecular sub-typing, following the recommendations in the international guidelines and existing standards. WP2.3 IMPLEMENTATION OF REGULAR EQA ROUNDS, DATA MANAGEMENT and ANALYSIS: Following initial proficiency test round and EQA workplans (see D2.11, 2.12) perform regular follow-up EQA rounds, collecting and analysing EQA results from a panel of TB control strains from countries each year, upon confirmation of budget availability. WP3. TRAINING IS PREPARED AND TRAINING INITIATIVES IMPLEMENTED, WITH THE OVERALL AIM TO STRENGTHEN MS CAPACITY IN TB DIAGNOSIS, DRUG SUSCEPTIBILITY TESTING, AND INTERNATIONAL COORDINATION

WP3.1 IDENTIFY TRAINING NEEDS

Identify training needs and develop appropriate curriculum for a laboratory workshops, EQA task forces, and staff exchange programmes or lab twinning to:

• teach and strengthen performance of traditional diagnostic methods, drug sensitivity testing, molecular subtyping, and other specialized analytical techniques for TB as well as other more general topics such as biosafety, laboratory management and quality control issues in the context of working with TB material and

• improve performance on EQA rounds

• develop a cadre of TB experts for transverse functions in peer review of laboratory performance and other types of country visit support and exchange programmes

WP3.2 IMPLEMENTATION OF TRAINING PROGRAMMES

There are 3 types of training envisaged for the project to be implemented based on the needs analysis WP3.1:

• TB Laboratory Training workshops - Goal of workshops are to disseminate methods and to identify future needs; the training material has to be provided. The topics, agenda, invitation list, location and the trainers will be agreed with ECDC.

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• EQA Training task forces - Based on the results of the EQA, organise specialised task forces for training to assist laboratories in the consortium to improve on specific methods or difficulties.

• TB Laboratory staff exchanges and/or lab twinning arrangements - short personnel exchanges to train on and develop specific methods to improve characterisation of pathogens and/or specialized reference techniques and to promote collaboration between the consortium members and relevant research institutes.

It is planned that such activities will be coordinated by the applicant but implemented by third party designated specialists in the area. The overall aim of the training initiatives shall be to strengthen MS capacity in TB diagnostic services, to increase collaborations and networking, and to improve comparability of TB surveillance data.

For estimation of costs for training initiatives on which to base the offer, please use as a guide the following suggestions:

• For laboratory workshops - at least one large (max. 40 participants – at least 1 per ERLN-TB partner) and/or several smaller laboratory training workshops (10-15 participants to cover needs of topic areas) are requested per 12 month period of framework agreement and in consultation with ECDC. Cover the travel, accommodation and relevant subsistence expenses for all the participants in the workshop (maximum 3 days per workshop). Travel and accommodation for ECDC staff will be covered by ECDC. Expenses by the applicant should be included in the budget estimation;

• “Task force” site visits should be estimated to a maximum of 5 per 12 month

period of framework agreement (with a maximum of 2 persons on the visit for the budget estimation) unless otherwise justified by the results of the WP2. Training involving exchanges of personnel should be estimated to a maximum of 10 staff exchanges per 12 month period of framework agreement and justified on case to case basis together with ECDC. For these training initiatives, cover the travel, accommodation and relevant subsistence expenses for the task force and/or all the training exchanges for up to maximum 1 week. The travel and accommodation costs for ECDC staff will be covered by ECDC. Expenses by the applicant should be included in the budget estimation;

2.6. Meetings:

For the meetings (including laboratory training workshops), the successful Applicant shall carry out the following tasks:

• Propose the list of participants and seek ECDC input and approval prior to the meeting and provide the scope and purpose of the meeting. Provide a final list of participants, including their affiliation and contact details, at the meeting. Make it available to ECDC in an electronic copy.

• Ensure the delivery of the full meeting, including:

• Organize travel and accommodation for all participants. Cover all costs related to the travel, subsistence and accommodation of all participants.

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Travel, accommodation and subsistence for ECDC staff, will be covered by ECDC according to its internal procedures.

• For meetings occurring outside ECDC, provide catering for all participants.

• The successful applicant will be paid, for covering the costs of the participants, the country-specific fixed rate indicated in Annex VI Rules on Eligibility of Costs of the draft agreement per participant and per day, after conclusion of the module, upon proof of participation by a participants’ list signed by each participant for each meeting day.

• For meetings occurring outside ECDC premises, provide the meeting venue as appropriate, ensuring smooth implementation and ideal working conditions; including all relevant material such as personal computer, overhead projector, video projector, power point and beamer, screens, flip charts (with paper and pens), easy access to printer, photocopier (with sorter and stapler function); and including coffee breaks and water on the table during meetings.

• The meetings are held in English.

• Provide printed material related to the meeting.

• Ensure the relevant support to allow for the smooth organisation and implementation of the meeting.

• Ensure that all participants sign the participants list for each day of the meeting.

• Collect presentations.

• Write a short report of the main discussion points of the meeting, including the recommendations and action points.

• Provide the meeting material and report

2.7. Place of performance of the contract

The implementation of the contract will be carried out at the successful applicant premises except for some of the ERLN for TB Management team meetings (at least 1 annually) and at least one of the Annual meetings of the network (suggest kick off and/or final meetings to be held at ECDC, Stockholm) (maximum 10 days overall per year).

2.8. Expected time frame

The applicant should provide ECDC with an expected time frame for each of the requested deliverables and activities proposed with particular attention to describing in detail the first year activities (i.e. please fill in Gannt Chart provided – section 2.14).

The expected time frame of the implementation is four years. An interim evaluation of the work achieved by the successful applicant will be performed by ECDC before the end of the second year of the framework partnership agreement and recommendations made for follow-up of the project implementation for the next 2 years according to the process described below (section 2.9)

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2.9. Characteristics of the agreement object of the call of proposals

ECDC wishes to conclude a framework partnership agreement with one applicant or a consortium of partners. The duration of this agreement is planned to be four years. After the first two years implementation, further implementation is subject to the outcomes of the first two years. The last two years will be renewable annually. The framework partnership agreement establishes the framework of the deliverables and requires an additional step to make the actual implementation. This is in the form of a specific grant agreement specifying the details for each particular implementation, based on the previously signed framework partnership agreement, and specifying the resources used. Due to calendar planning and in order to group processes, the submission of the first specific grant agreement is already requested with this application (see Section 3.1 concerning year 1). The first specific agreement implementation is split in two phases; the second phase is confirmed only after approval of the deliverables and payment concerning the first 50% of the budget estimation, for the first specific agreement. The specific agreements after the first renewal will be subject to budget availability confirmation.

The successful Applicant shall coordinate a consortium with other Institutions in all EU/EEA Member States and where appropriate to extend some activities to candidate and accessing EU countries. The successful Applicant must submit the details of institutions involved. A consortium arrangement between partners will ensure pooling of existing European knowledge and expertise in this area.

The signature of the agreements shall be by one Lead Institute, the Coordinator of the consortium. Partner institutions give mandate to the Lead Institute for the performance of the agreement.

The coordinator shall ensure that consortium partners complete the formalities for them to accede to the contractual agreement. (see Article I.2 of the model Framework Grant Agreement in Annex II), including the duly completed and signed originals of Form A (set out in Annex III).

Under each item of the description of the work packages below it is specified what should be done during the first year specific grant agreement.

2.10. Work Packages and related activities

The applicant should develop and submit an outline of the project and comprehensive description of activities in WP1-3 to be undertaken in the first year of project to ECDC, for the specific grant agreements to be initiated in 2009 and finalised by first half of 2010.

List of Deliverables for first year (to be put in Excel) Indicative Duration

WP1. The European reference laboratory network for Tuberculosis (ERLN-TB) is fully established and its co-ordination is ensured

1.1 ANNUAL MEETING AND CO-ORDINATION

D1.11 – the TB reference laboratory network (ERLN-TB) with agreed Months 1-3

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members is set up

D1.12 – an annual meeting is organised with all ERLN-TB network members and meeting notes are provided

Months 3-6

D1.13 – an annual report on project implementation, comprising all the Work Packages is provided

Month 12

1.2 ERLN-TB MANAGEMENT TEAM

D1.21 – a ERLN-TB management team with agreed members (maximum 5) is set up

Months 1-3

D1.22 – regular feedback (monthly teleconference and meeting notes/minutes) from ERLN-TB management team meetings is provided (m1-48)

Months 1-12

1.3 METHODS OF HARMONISATION

D1.31 –a handbook of TB diagnostic methods, which includes the establishment of standards, is compiled

Month 12

D1.32 - a workplan/roadmap for methods harmonisation (annex of annual report or separate document) is provided including the following chapters:

Month 12

· provide list of areas/methods where standards development is feasible, useful, and would give EU added value (i.e. DST testing, in particular for second line drugs and description of cut-off points)

· provide overview of projects/initiatives at EU level where methods are currently being harmonised (i.e. please include EU-CAST, Molecular subtyping projects, DST projects under the WHO and EC support etc…)

· provide a roadmap of plans for merging the ongoing activities and identify future activities of this network for harmonization of methods

1.4 REFERENCE SERVICES

D1.41 – a list of available and needed reference services and relative costs per service are developed with the ERLN-TB partners

Month 7

D1.42 – annual feedback on acting collaborations and on the use of these reference services (part of the annual reports)

Month 12

1.5 EU STRAIN/SAMPLE COLLECTION

D1.51 – a workplan/roadmap for development of an EU strain/sample collection is provided (annex of annual report or separate document)

Month 12

D1.52 – a workplan is implemented and an interim report on milestones Months 7-12

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and work progress is provided

1.6 ALERT and RESPONSE

D1.61 – ERLN-TB participate in and promote ECDC’s alert and response collaboration platforms to TB colleagues/community of experts (part of management teamwork and/or annual meetings)

Months 1-12

D1.62 – annual feedback on contributions of TB experts to alert and response systems of ECDC (part of the annual reports)

Month 12

1.7 SCIENTIFIC EXCELLENCE and ADVICE

D1.71 – ERLN-TB partners participate in and promote ECDC scientific expert activities to TB colleagues/community of experts (part of management team work and/or annual meetings)

Months 1-12

D1.72 – scientific articles are produced from ERLN-TB activities (see section 2.11 – subject of contract for details)

Months 1-12

WP2. External quality assurance (EQA) schemes on provision and promotion of TB laboratory methods are planned and baseline performance established

2.1 ESTABLISHMENT OF THE CURRENT PERFORMANCE

D2.11 – information of past proficiency exercises is compiled and design of next phase of proficiency testing rounds to establish baseline in needed areas is prepared (planning phase)

Months 1-3

D2.12 – a baseline of performance is established (i.e. execute a proficiency testing round with ERLN-TB partners) for selected first and second line drugs and other needed areas based on D2.11 (m3-7 execute phase of EQA rounds, report as part of first annual report m12 and/or separate scientific paper of results)

Months 3-7, 12

WP3. Training is prepared and training initiatives implemented, with The overall aim to strengthen MS capacity in TB diagnosis, drug susceptibility testing, and international coordination

3.1 IDENTIFY TRAINING NEEDS

D3.11 - training needs in laboratory methods, diagnostics and other areas are identified in EU, EEA/EFTA Member States and candidate countries

Months 1-7

3.2 IMPLEMENTATION OF TRAINING PROGRAMMES

D3.21 - a curriculum and training materials and initiatives are developed and implemented for laboratory workshops, EQA task forces, and for laboratory exchange programmes

Months 7-12

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Further activities beyond the first year of the project for all the Work Packages (WP 1-3) should be outlined in the Management and Communication Plan described in section 3.3.

2.11. Amount available for financial support and provisions about the results

The estimated grant for the first year of the project (covering all activities in WP1-WP3) is 300,000 EUR. For the successive years the grant amount will be determined time by time, contingent on the available budget and on the work plan of ECDC. Funding available for years two to four is indicatively 300 000 EUR / year, subject to budget availability and the performance on work packages WP1-WP3.

For the activities of the first specific grant agreement, expected to commence in 2009, maximum funding available from ECDC is 300,000 EUR.

The ECDC will contribute 90% of the total eligible costs and the successful applicant will co-finance the remaining 10% of the total eligible costs.

Applicant must apply the Rules on eligibility of costs (see Annex VI of this Call). The ultimate aim is an active cooperation between ECDC and the successful Applicant for the duration of the project.

Ownership of the outcomes obtained during and from the project implementation (action, work packages), including industrial and intellectual property rights, and of the reports and other documents relating to it shall be vested in the ECDC.

The applicant should agree with the ECDC the policy that the owners of strains, nucleic-acid samples and results will be the country who submitted the strain, nucleic-acid sample or typing result. The owner of all the documentation, all data in the database and the database itself will be the ECDC. No publications can be made without agreement of data owner(s) and the ECDC. ECDC should have co-authorship of any scientific publication and communication produced by the awarded applicant.

Without prejudice to the previous paragraph, the ECDC grants the partner the right to make use, subject to prior written consent of ECDC, of the results of the project (action), provided it does not thereby breach its confidentiality obligations or existing industrial and intellectual property rights.

ECDC should be acknowledged / mentioned as provider of funding on all communications meaning the ECDC logo and a disclaimer will be put on all reports, web site, bulletins, etc. All activities and products will be transferred to ECDC after the completion of the agreement. During the project period, a detailed transition plan will be developed in close collaboration with the Coordinator so that at the end of this agreement subsequent activities will be coordinated by ECDC.

2.12. Reporting requirements

The following reports are requested to be submitted:

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The reports related to the deliverables of the call for proposal, in particular:

WP1 – annual reports due at latest month 12, 24 36, 48. It is requested that a good draft of these reports is submitted 1 month before these deadlines to allow for revision and comments by ECDC and relevant parties.

WP1-3 – any other reports or documentation relevant as mentioned above in the description of the activities and deliverables of the work packages

The reports related to the financial management of the implementation:

• A financial statement supporting the request for payment: The costs here declared by the partner shall be real, accurately recorded and eligible, in accordance with the framework agreement and the specific agreement. The supporting documents are not requested to be submitted and are kept by the partners, according to their accounting and internal auditing procedures. They must permit direct reconciliation of the costs and revenue declared for the implementation with the corresponding accounting statements and supporting documents, in compliance with Article II.22 - Checks and Audits of the agreement.

• A comprehensive condensed technical report on the implementation

• Relevant written correspondence, including ECDC’s approval on any item mentioned above

2.13. Payments

Payments for the year 1 Specific Grant Agreement will be performed as follows:

• 40% pre-financing upon receipt of a request for pre-financing that can also be submitted together with the agreement for signature.

• Up to 50% interim payment (40% covered by the previous pre-financing) by mid-November 2009, based on actual costs.

• Interim payment to reach up to 75% of the project by month 9, based on actual costs and implementation of deliverables.

• Balance final payment upon receipt and approval of a final invoice, final financial and technical report, the related supporting documents, all the deliverables and scientific paper ready for submission.

For specific grants agreements for the successive years, the payment schedule will be established when there is the request for resources allocation and budget.

2.14. Indicative time frame 1st year

Please propose a detailed work plan and timeline (i.e. Gantt chart) for the implementation of year 1, considering that the major part of the implementation is expected by mid November 2009, and the finalization by the first half of 2010.

months 1 2 3 4 5

6

7 8

9 10 11 12

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Activity

WP n (title of work package)

1.1 (name of activity)

1.2 ...

1.3 …

…

2.15. Implementation of the Work Packages in years 2 to 4

By the end of each 9 month of the project annuality, the successful applicant is requested to present a detailed description of the planned activities and deliverables for each of all the Work Packages, concerning each next year, including the relative budgets and workplan, with timeline, approach and list of milestones and deliverables.

3. CONTENT OF THE APPLICATION

3.1. THE DEADLINE FOR APPLICATION IS 3 JUNE 2009

3.2. The proposal to submit to ECDC should include:

• An outline of the whole project.

• A detailed description of the planned work for the first year (include Gannt Chart – section 2.14) WP1-3 together with a proposed list of the countries/laboratories/experts that will make up the ERLN for TB consortium, with an explanation of the allocation of tasks and implementation of work packages

• An outline of further activities to be conducted year 2-4 under WP1-3. The detailed description of activities and deliverables for year 2-4 for all work packages (WP 1-3) will only be discussed and negotiated afterwards, based on an invitation by ECDC to submit a proposal in accordance with Article I.4 of the framework partnership agreement and taking into account the budgetary context at that time.

The proposal from an Applicant should include a technical and budget proposal per Work Package.

3.3. Management and Communication Plan

A preliminary project Management plan should be designed and submitted as part of the proposal for this grant.

The Management plan should clearly describe members of this consortium (Associate Partners) and delineate responsibilities. It should describe the project organisation i.e. a Coordinator, Project Leader, Project Manager, Associate Partners. The Management Plan should also include a Communication Plan (see below). Description of project

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organisation should also include the interaction with the Steering Committee. A project organigram showing links between participating partners should be included.

The Communication Plan should outline both internal and external communication.

(a) The internal component of the Communication Plan should include organising, conducting and chairing meetings of the Management Team.

(b) The external component of the Communication Plan relates to the dissemination of the final results and should be further detailed.

3.4. Estimated budget

Within the total budget, the applicant is free to propose particular implementations with the corresponding budget allocation to the activities, providing that the project proposal remains focussed on the main objectives and deliverables. As the project progresses, eventual updates shall be discussed with ECDC and as indicated by the agreement.

4. EVALUATION OF THE PROPOSALS

After having verified the compliance with all the submission requirements (see 4.1), ECDC selects the admissible proposals through a procedure that involves 4 types of evaluation criteria in this order: (1) eligibility criteria (see 4.2), (2) exclusion criteria (see 4.3), (3) selection criteria (see 4.4), (4) award criteria (see 4.5). If the submission requirements are not met, the proposal is not passed to the next step of the evaluation criteria. If one of the evaluation criteria is not met, the proposal is not passed to the next steps of the evaluation criteria. It is therefore essential to complete the proposal in full and provide all the supporting documents requested. The proposal proposed for award is the one, among those evaluated with the award criteria, which has the best score.

An Evaluation Committee will be established in accordance with article 116 of the Financial Regulation and article 178 of its Implementing Rules in order to evaluate the submitted proposals. ECDC intends to finalise the evaluation of proposals within one month since the final deadline for submission of proposals. In compliance with article 116 (3) of the Financial Regulation, the applicant will be informed in writing of the decision on their proposal. Please note that ECDC has the right not to award a grant and to cancel the procedure at any time before the signature of the agreement without any compensation to be paid to the applicant. General principles: In compliance with the Financial Regulation and its Implementing Rules, the proposals must comply with the following principles: • Co-financing rule: external co-financing from a source other than EU budget is required as indicated in part 2.7.

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• Non-profit rule: the grant may not have the purpose or effect of producing a profit for any of the applicant; • Non-retroactivity rule: the costs eligible for financing must be incurred after the starting date stipulated in the agreement; • Non-cumulative rule: only a single EU grant may be awarded for a specific project carried out by a given beneficiary in one financial year. .

4.1. Verification of submission requirements

The following will be assessed: • The final deadline for submission of proposals: If this deadline has not been respected the proposal will automatically be rejected. • The proposal is duly signed by the duly authorized representative of the consortium. If the proposal is not signed then it may be rejected on that sole basis. • The proposal is complete, including all supporting documents and in accordance with the model structure (Annex I). If any of the requested information/documents is missing or is not complete the proposal may be rejected on that sole basis. The proposal which meets all the submission requirements will be considered admissible and will pass to the next stage of evaluation process – verification of eligibility criteria.

4.2. Eligibility criteria

Consortia consisting of at least two partners (natural/legal persons, private or public), these partners being established in different ECDC member countries (the 27 EU Member States and EEA/EFTA counties which are Iceland, Liechtenstein and Norway), are eligible.

A LEGAL ENTITY FORM has to be completed and signed separately by the applicant (each partner of the consortium). This legal entity form should be returned together with a copy of the public legal act establishing the entity in question or failing that, any other official document attesting to the establishment of the entity, clearly indicating it pursues public interest objectives. ECDC provides a template to be used – Annex V.

4.3. Exclusion criteria

Article 114(2) of the Financial Regulation states that “Grants may not be awarded to applicant who are, at the time of a grant award procedure, in one of the situations referred to in Articles 93 and 94”. Accordingly, applicant and possible partners must certify that they are not in one of the following exclusion situations:

• (a) they are bankrupt or being wound up, are having their affairs administered by the courts, have entered into an arrangement with creditors, have suspended business activities, are the subject of proceedings concerning those matters, or are in any analogous situation arising from a similar procedure provided for in national legislation or regulations;

• (b) they have been convicted of an offence concerning their professional conduct by a judgment which has the force of res judicata;

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• (c) they have been guilty of grave professional misconduct proven by any means which the contracting authority can justify;

• (d) they have not fulfilled obligations relating to the payment of social security contributions or the payment of taxes in accordance with the legal provisions of the country in which they are established or with those of the country of the contracting authority or those of the country where the implementation is to be performed;

• (e) they have been the subject of a judgment which has the force of res judicata for fraud, corruption, involvement in a criminal organisation or any other illegal activity detrimental to the Communities' financial interests;

• (f) following another procurement procedure or grant award procedure financed by the Community budget, they have been declared to be in serious breach of contract for failure to comply with their contractual obligations.

In addition, grants may not be awarded to applicant who, at the time of the selection procedure:

• (a) are subject to a conflict of interest;

(b) are guilty of misrepresentation in supplying the information required by ECDC as a condition of participation in the award procedure or fail to supply this information.

• (c) find themselves in one of the situations of exclusion listed above.

Applicant must certify that they are not in one of the situations listed above by signing the attached Declaration on Honour (Annex IV). The Declaration on honour is to be completed and signed separately by each consortium partner. The consortium with which the partnership agreement will be signed must provide evidence confirming the declaration referred to in the previous point.

4.4. Selection criteria

In the case of a consortium submitting an offer, each member of the consortium must provide the required evidence. For ‘technical capacity’ the evidence provided by each member of the consortium will be checked at consortium level to ensure that the consortium fulfils the criteria.

Financial capacity:

Evidence of the consortium’s economic and financial capacity shall be furnished by the following documents:

- Commitment to provide the necessary financial coverage for the project implementation cash flows and for the 10% co-finance requirement, in order to maintain the consortium’s activity throughout the 4 year partnership period;

- for private partners: profit and loss accounts, balance sheet for the last financial year for which the accounts were closed (and audit reports by an approved external auditor certifying the accounts for the last available financial year).

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If, for any valid reason, the service provider is unable to provide the references requested by the contracting authority, he may prove his economic and financial standing by any other document which the contracting authority considers appropriate.

Technical and professional capacity

The Applicant must have the following technical capacity to perform the contract:

The Applicant must have the following professional capacity to perform the contract: • The Applicant must be registered in a relevant commercial or trade

register. This condition does not apply for public bodies. Evidence of this capacity must be provided by:

• The Applicant must provide evidence of enrolment (declaration or certificates) in one of the professional trade registers in its country of establishment.

• If the Applicant is not required or permitted to enrol in such a register for reasons of his statute or legal status, an explanation should be provided.

Requirements for the host institution

The host institution of the coordinating centre for the European Reference Laboratory Network for TB should fulfil the following requirements:

- host a laboratory with a significant amount of activity in TB reference laboratory services related to TB diagnostics and molecular typing

- have strong links with National Public Health and Surveillance Systems and preferably be a National Reference Centre for TB

- have appropriate infrastructure to perform trainings regarding to this call for proposal

- have the administrative capacity to execute the budget of the proposal.

Requirements for the coordinator

- is a biologist, molecular biologist, bacteriologist or a professional with relevant education for this duty with at least a PhD in bacteriology or related scientific field; with at least 5 years post doctoral working experience in the field of bacteriology or clinical microbiology;

- proved evidence of strong managerial skills - has an active role in the daily work of the laboratory and data analysis. - International experience and liaison work with relevant initiatives of the WHO

and the European Commission

Requirements for the network members

- Proven experience in setting up and performing of EQA in the TB diagnostic field. Have a recognized TB reference laboratory function in the Country that will be confirmed with consultation between ECDC and the Member State Competent Body.

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- The applicant should prove their experience in providing training in TB diagnostics, molecular typing methods, EQA, and other areas related to TB laboratory services and laboratory technical consultancy functions, including performance of laboratory assessments to support country visits.

The applicant shall provide:

Evidence of the consortium’s technical and professional capacity to carry out the envisaged project shall be furnished on the basis of the following documents:

• CVs of staff involved

• Letter of commitment (including statement of project participation and for at least 10% co-financing of the total eligible costs of the workpackages that they are involved in) of the person who will act as the coordinator and as well from the consortium members once they are appointed in the process described in WP1.

• Certificate on accreditation regarding to the international standards (ISO, etc.)

• Documentation of required evidence covered by this framework agreement in the past five years (i.e. coordination and scientific work, EQA experience in TB, training modules organised, etc…).

• Documentation showing the applicant’s experience and knowledge on basic TB diagnostics and reference level services and methods (especially for drug susceptibility testing), training provided, molecular typing methods with regard to TB.

• The 10%-rule of minimum co-financing is applied towards the consortium as a whole. To what extent partners contribute to this co-financing is an internal consortium matter. Before awarding any grant through Specific Agreements (SAs) based on Framework Partnership Agreements (FPA(s)), (the) consortium(a) must furnish proof of the amount of co-financing to be provided (Article I.6.2 FPA).

• A presentation of the organisation of consortium and its internal organisation. Proposals must specify the role, qualifications and experience of each of the members of the consortium.

• Language abilities: statement of the candidate’s language abilities. Most of the work will be performed in English. The core staff/key experts must demonstrate a strong ability to draft and operate in this language and provide references to previous work.

4.5. Award criteria

The framework agreement will be awarded to the proposal which will obtain the highest score, taking into account the following criteria; no award criteria and sub criteria others than these will be used to evaluate the proposal.

Award criterion 1: Technical implementation

i) Understanding of the context ii) Degree to which the proposed implementation responds in a credible

way to the call for proposals iii) How the deliverables are apt be disseminated and have an impact

25 points

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(The above aspects are of the same relative value)

Award criterion 2: Methodology

i) Soundness of the proposed technical aspects of the project - i.e. Content and quality of the proposed methods for carrying out the deliverables of the WP1-3

ii) Use of the appropriate resources for carrying out the planned tasks (The above aspects are of the same relative value).

30 points

Award criterion 3: Project team and management

i) Allocation and management of resources and expertise ii) Coordination and mobilization of the team and possible subcontractors iii) Realistic time deadlines for completion of tasks and work plan iv) Verifiable objectives and milestones v) A group of relevant partners who work together as a multi-disciplinary

team (The above aspects are of the same relative value)

25 points

Award criterin 4: Cost effectiveness

The extent to which the estimated budget is cost-effective (comparison between estimated cost and anticipated achievement of objectives/results).

20 points

Minimum attainment per award criterion

Proposals scoring less than 60% for any award criterion will be deemed to be of insufficient quality and eliminated from further consideration.

Minimum attainment overall

Proposals scoring less than 60% after the evaluation process will be considered to be of insufficient quality and eliminated from the following phase.

5. ANNEXES

I. Model proposal (structure) II. Model of Framework Partnership agreement III. Form A – Form B – Model of Specific grant agreement IV. Declaration on honour on exclusion criteria V. Financial identification and legal entity forms

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VI. Rules on eligibility of costs VII. List of previous/current EU grants VIII. Estimated Budget